RELUGOLIX - Generic Drug Details

What are the generic sources for relugolix and what is the scope of patent protection?

Relugolix is the generic ingredient in one branded drug marketed by Sumitomo Pharma Am and is included in one NDA. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Relugolix has one hundred and ninety patent family members in thirty-seven countries.

One supplier is listed for this compound.

Summary for RELUGOLIX

International Patents:	190
US Patents:	11
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	54
Clinical Trials:	48
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RELUGOLIX
What excipients (inactive ingredients) are in RELUGOLIX?	RELUGOLIX excipients list
DailyMed Link:	RELUGOLIX at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for RELUGOLIX

Constraining patent/regulatory exclusivity:

10,350,170

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for RELUGOLIX

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	PHASE3
University of Michigan	PHASE3
University of Utah	PHASE2

See all RELUGOLIX clinical trials

Pharmacology for RELUGOLIX

Drug Class	Gonadotropin Releasing Hormone Receptor Antagonist
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2B6 Inducers Cytochrome P450 3A Inducers Gonadotropin Releasing Hormone Receptor Antagonists P-Glycoprotein Inhibitors
Physiological Effect	Decreased GnRH Secretion

Anatomical Therapeutic Chemical (ATC) Classes for RELUGOLIX

L02BX	Other hormone antagonists and related agents
L02B	HORMONE ANTAGONISTS AND RELATED AGENTS
L02	ENDOCRINE THERAPY
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for RELUGOLIX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ORGOVYX	Tablets	relugolix	120 mg	214621	6	2024-12-18

US Patents and Regulatory Information for RELUGOLIX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sumitomo Pharma Am	ORGOVYX	relugolix	TABLET;ORAL	214621-001	Dec 18, 2020		RX	Yes	Yes	8,058,280		Y	Y
Sumitomo Pharma Am	ORGOVYX	relugolix	TABLET;ORAL	214621-001	Dec 18, 2020		RX	Yes	Yes	11,795,178		Y	Y
Sumitomo Pharma Am	ORGOVYX	relugolix	TABLET;ORAL	214621-001	Dec 18, 2020		RX	Yes	Yes	12,144,809

Expired US Patents for RELUGOLIX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sumitomo Pharma Am	ORGOVYX	relugolix	TABLET;ORAL	214621-001	Dec 18, 2020	8,735,401

EU/EMA Drug Approvals for RELUGOLIX

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Accord Healthcare S.L.U.	Orgovyx	relugolix	EMEA/H/C/005353Orgovyx is indicated for the treatment of adult patients with advanced hormone-sensitive prostate cancer.	Authorised	no	no	no	2022-04-29

International Patents for RELUGOLIX

Country	Patent Number	Title	Estimated Expiration
Canada	3038879
Serbia	63199
Canada	3038879

Supplementary Protection Certificates for RELUGOLIX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1591446	21C1056	France		PRODUCT NAME: RELUGOLIX OU UN SEL DE CELUI-CI; REGISTRATION NO/DATE: EU/1/21/1565 20210720
1591446	CR 2021 00048	Denmark		PRODUCT NAME: RELUGOLIX OR A SALT THEREOF; REG. NO/DATE: EU/1/21/1565 20210720
1591446	C 2021 047	Romania		PRODUCT NAME: RELUGOLIX SAU O SARE A ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/21/1565; DATE OF NATIONAL AUTHORISATION: 20210716; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1565; DATE OF FIRST AUTHORISATION IN EEA: 20210716

Market Dynamics and Financial Trajectory for RELUGOLIX

Last updated: July 29, 2025

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Introduction

Relugolix is an oral gonadotropin-releasing hormone (GnRH) antagonist developed by Pfizer, approved for conditions such as prostate cancer, endometriosis, and uterine fibroids. Its mechanism involves rapid suppression of sex hormone production, offering an alternative to injectable therapies with potentially fewer side effects. As the pharmaceutical landscape evolves, understanding the market dynamics and financial trajectory of Relugolix is essential for stakeholders seeking to gauge its commercial prospects and strategic positioning.

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Market Drivers and Opportunities

Expanding Therapeutic Applications

Relugolix's versatility spans multiple indications, fueling market expansion. Initially approved in the United States in December 2020 for advanced prostate cancer, its subsequent approval by the FDA in 2021 for women’s health conditions—endometriosis and uterine fibroids—has broadened its commercialization scope. These diverse indications open revenue streams across urology, gynecology, and oncology sectors.

Shift Toward Oral Hormonal Therapies

The transition from injectable GnRH formulations to oral alternatives aligns with patient preference for convenience and improved compliance. Relugolix’s oral administration enhances its market appeal, especially in outpatient settings, reducing healthcare costs. This trend gains momentum amid the COVID-19 pandemic's push toward outpatient and home-based treatments.

Competitive Landscape and Differentiation

Relugolix faces competition from established therapies like Lupron (leuprolide) and other GnRH agonists, which are injectable and have long been the industry standard. However, its rapid onset of action, reversible effects, and oral delivery position it favorably. Its marked profile as a “first-in-class” oral GnRH antagonist enhances its differentiation, especially in women’s health indications.

Regulatory and Reimbursement Environment

Positive regulatory decisions and supportive reimbursement policies significantly influence market penetration. Pfizer’s strategic engagement with healthcare stakeholders ensures coverage and awareness, vital in the complex landscape of drug adoption.

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Challenges and Risks

Market Penetration Barriers

Despite advantages, Relugolix faces hurdles such as clinician familiarity with existing therapies and the conservative nature of prescribing habits. Overcoming entrenched preferences for injectable GnRH agents requires targeted educational initiatives and robust clinical evidence.

Pricing and Reimbursement Constraints

Pricing strategies influence adoption rates. As a novel oral agent, Relugolix may command premium pricing initially, which could encounter resistance from payers seeking value-based agreements. Reimbursement negotiations could temper revenue growth if price points are not acceptable.

Patent and Competitive Risks

Patent life constraints and potential generic entry pose long-term revenue risks. Other innovative therapies entering the market or new formulations may threaten Relugolix’s market share.

Market Access and Patient Compliance

Ensuring widespread access and demonstrating adherence benefits over injectable or alternative therapies are crucial. Non-compliance or misprescribing could dampen expected financial returns.

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Financial Trajectory and Revenue Expectations

Initial Sales Performance

Pfizer launched Relugolix with an initial focus on prostate cancer, where unmet needs remain significant. Early uptake hinges on physician acceptance, insurance coverage, and patient awareness. In the U.S., the drug's pricing was set at approximately $425 per month for prostate cancer treatment, corresponding with other oral hormonal therapies[1].

In women’s health indications, market entry was supported by clinical trial data demonstrating non-inferiority to injectable GnRH agonists (e.g., leuprolide), potentially accelerating adoption. Preliminary estimates suggest robust initial sales, with forecasts indicating a potential for annual revenue in the range of $500 million to $1 billion within five years, contingent on market penetration rates[2].

Long-term Revenue Projections

The sustained financial success depends on expanding indications, geographic expansion, and overcoming competition. If regulatory approvals and formulary placements proceed smoothly, market analysts project that Relugolix could reach peak sales exceeding $1.5 billion globally by 2027. The US market accounts for approximately 50-60% of this revenue, with Europe and Asia holding emerging growth opportunities.

Investment and R&D Impact

Pfizer’s commitments involve investments in clinical trials, post-marketing surveillance, and marketing campaigns. The cost structures associated with these initiatives influence short- and long-term profitability. However, the drug’s strategic positioning as a first-in-class therapy enhances potential pricing power and market share gains.

Regulatory and Market Expansion

Potential approvals for additional indications such as prostate or breast cancer, or for conditions like leiomyomas in larger populations, could significantly elevate revenue trajectories. Moreover, partnerships and licensing agreements in emerging markets underpin global expansion strategies.

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Market Challenges and Strategic Considerations

Pricing Strategies: Achieving a balanced price point that reflects Relugolix’s clinical benefits while ensuring payer acceptance is critical for sustainable revenue.

Market Access: Establishing formulary inclusions and clinician awareness campaigns will be essential to accelerate uptake.

Pipeline Development: Demonstrating efficacy in additional indications or combination therapies can unlock new revenue streams.

Competitive Innovation: Monitoring and responding to emerging oral GnRH antagonists or innovative delivery systems will be vital.

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Conclusion

Relugolix’s market dynamics are shaped by its innovative oral administration, expanding indications, and the shifting landscape toward personalized, patient-friendly therapies. The financial trajectory forecasts promising growth, driven by early success in prostate and women’s health indications, with potential for substantial revenue if market access barriers are overcome and regulatory hurdles are managed effectively. Strategic positioning, pricing, and ongoing clinical development will remain pivotal in realizing its full financial potential.

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Key Takeaways

• Diversified Indications Drive Growth: The expansion from prostate cancer to women’s health indications significantly broadens Relugolix’s market opportunities.
• Oral Administration Offers Competitive Advantage: The oral GnRH antagonist route enhances patient compliance and clinician preference over injectable formulations.
• Market Penetration Depends on Adoption Strategies: Physician education, reimbursement policies, and clinical data influence the pace of adoption.
• Revenue Potential Remains Strong: Market forecasts project peak sales exceeding $1.5 billion globally by 2027, contingent on market expansion and competition.
• Long-term Success Requires Pipeline and Market Strategy: Developing additional indications and navigating global regulatory landscapes will be crucial for sustained growth.

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FAQs

1. What are the primary indications for Relugolix?
   Relugolix is approved for advanced prostate cancer, endometriosis, and uterine fibroids, providing hormonal suppression in these conditions.

2. How does Relugolix differ from traditional GnRH therapies?
   Unlike injectable GnRH agonists, Relugolix is an oral, rapid-acting GnRH antagonist, offering reversible suppression with potentially fewer side effects.

3. What are the main challenges facing Relugolix’s market growth?
   Challenges include clinician familiarity with existing therapies, reimbursement and pricing hurdles, patent expiration risks, and competition from emerging therapies.

4. What is the revenue outlook for Relugolix over the next five years?
   Peaking at over $1.5 billion globally by 2027, contingent on successful indication expansion and market adoption.

5. Are there plans to expand Relugolix’s indications further?
   Yes. Ongoing clinical trials investigate its efficacy in various oncological and gynecological conditions, potentially broadening its market base.

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Sources
[1] Pfizer Official Pricing Information.
[2] MarketAnalyst Reports on Hormonal Therapies.